Understanding a PIS
After telling your doctor that you would like to join a clinical trial trial, or deciding that you would like to participate in one as a healthy volunteer, you will be given a Patient Information Sheet (PIS). The PIS includes full information about the trial and can be taken home to read in your own time. This sheet can then be used as a tool to discuss any further questions you may have with your doctor or specialist, or to help you explain the trial and what to expect to your friends and family.
Understanding an ICF
If you then decide to join the trial, you will be asked to sign a form to say you agree to take part in the trial, you understand what taking part means, and you know what to expect. This document is called an Informed Consent Form, also known as an ICF.
An ICF can be a very complicated document, so please make sure you go through anything you don’t understand with your doctor or one of the nurses associated with your trial.
If you take part in a clinical trial you will be monitored regularly during and after the trial. You may find your clinical trial involves you having a number of tests, appointments and some things which you may need to do at home. The tests that you will need to have will depend on the disease or condition that you have, and the trial you have entered. As an example, some common tests that may be used during clinical trials testing new treatments for cancer are shown below. However, make sure you understand the tests that are needed for any trial you are thinking of joining.
Where your doctor checks your body for any signs of disease or any changes in your general health.
Taking a small amount of blood for testing so that the trial doctor can closely monitor your health.
The use of magnetic and radio-waves/X-rays with a computer to generate detailed images of the inside of the body. They can be used to measure the effect of treatment.
The removal of a small sample of tissue for analysis in a laboratory.
A test used to monitor your heart and show any abnormalities in your heart rhythm. It is a completely painless procedure and will only take a few minutes.
Throughout a trial, you may need to attend a number of appointments. These will either be:
with your trial nurse
with your doctor
over the telephone
During a trial, there will also be a few things you will need to remember to do. These could include taking your study medication as directed by your doctor (if your trial involves you taking your own medication rather than it being administered by a nurse or doctor) and filling in a diary. Both of these things are very important.
Take your study medication correctly
Taking your study medication correctly ensures any information collected from the trial is accurate and also gives the treatment the best chance of working for you. Sometimes this can be difficult to do if you are already taking medication for another condition, some of the tips below may help you with this:
Stick to the same time each day
Use a pill box
Set an alarm
Develop a dosing schedule with your doctor or nurse (if you take other medicines as well as the study treatment)
Using a diary
Sometimes during a clinical trial, you will be asked to keep a patient diary. This allows your trial nurse or doctor to closely monitor your general health and any side effects you may experience from the study medication.
Things you may be asked to record in your diary include:
You may also want to record the dates and times of your tests and appointments